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Terminated

AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS

FDA Recall Z-0063-2007 · Posted 2006-10-24

Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeLLI
Date Initiated2006-09-27
Date Terminated2009-10-05
Product Quantity2065

Reason for Recall

The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation).

Firm Action

E-mails and letters regarding this correction provided to the consignees on September 27, 2006, and to appropriate Invacare personnel for information purposes. Consignees are being notified via delivery of a field correction package. Once the packages have been sent, a notice will be posted on the Invacare website. A follow-up contact will be scheduled in 2 to 3 months to try to reach those who have not returned their tracking sheet indicating completion of their corrective action.

Root Cause

Other

Distribution Pattern

United States and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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